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Trial record 58 of 256 for:    postpartum | "Depression"

Case Management Study for Postpartum Depression and Intimate Partner Violence

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ClinicalTrials.gov Identifier: NCT00560027
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Leonard & Helen R. Stulman Charitable Foundation
Information provided by (Responsible Party):
Barry Solomon, Johns Hopkins University

Brief Summary:
The objective of the study was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV) for women bringing their young infants for pediatric primary care and examine relationships between PPD, IPV and children's healthcare utilization from birth to 2 years.

Condition or disease Intervention/treatment Phase
Postpartum Depression Intimate Partner Violence Other: Case Management by Family Support Counselor (not RCT) Not Applicable

Detailed Description:

Post-partum depression (PPD) and intimate partner violence (IPV) negatively affect the health and well-being of millions of women each year. In turn, PPD and IPV frequently compromise women's ability to form a strong mother-infant bond, which potentially impacts their children's health and well-being. Limited information exists regarding the prevalence of PPD, IPV, and the co-occurrence of the two. Similarly, empirically tested interventions designed to improve outcomes for these women and their infants are lacking.

The objective of the research was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression and intimate partner violence and examine their relationships with children's healthcare utilization from birth to 2 years.

As per routine protocol in the Harriet Lane Clinic (HLC), all mothers bringing their infants for a well baby visit (birth to 6 month visit) are screened for PPD and IPV using a brief, self-administered paper-based questionnaire at the start of the visit. Appropriate resource and referral materials will be provided by a Family Support Counselor (FSC) in the clinic. Between February and March 2008, mothers bringing newborn, 2-, 4-, or 6-month-old children to an urban primary care clinic were screened for postpartum depression and intimate partner violence. A retrospective chart review abstracted demographic data, maternal responses on the postpartum depression/intimate partner violence screen at the initial and subsequent visits, and, from the child's birth to second birthday, adherence with well-child care and use of pediatric acute care and emergency department visits. Descriptive, bivariate, and multivariate analyses were conducted.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice
Study Start Date : July 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Case Management by Family Support Counselor (not RCT)
    N/A. Had planned to study RCT of case management intervention but unable to carry out RCT. Instead studied screening practice and healthcare utilization in mothers with PPD, IPV or both.


Primary Outcome Measures :
  1. Positive screens for PPD and/or IPV [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Healthcare utilization over 2 years (acute care, emergency and well visits) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking mothers of infants presenting for their newborn, two, four or six month visits to their primary care provider in the Harriet Lane Clinic

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560027


Locations
United States, Maryland
Harriet Lane Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Leonard & Helen R. Stulman Charitable Foundation
Investigators
Principal Investigator: Barry S Solomon, MD, MPH Johns Hopkins University
Principal Investigator: Megan Bair-Merritt, MD, MHS Johns Hopkins University

Publications:
Responsible Party: Barry Solomon, Associate Professor of Pediatrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00560027     History of Changes
Other Study ID Numbers: 20064046
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Barry Solomon, Johns Hopkins University:
postpartum depression
intimate partner violence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications